Optimization of therapy in adult patients with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma by individualised, targeted and intensified treatment

Phase 1

• Conditions: ewly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphomaAge 18 to 55 y; MedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10065923Term: Lymphoblastic lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-003466-13-DE
• Lead Sponsor: Goethe University Frankfurt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-05
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Acute lymphoblastic leukemia (all subtypes except burkitt leukemia, blasts in BM = 25%
or
• Lymphoblastic lymphoma (B- or T-lineage), blasts in BM <25%

• Age: = 18 - = 55 years

• Written Informed consent to participate in the study and the GMALL registry

• Women of childbearing potential (WOCBP) and male sexual partners of WOCBP must be willing to use an effective method of contraception (Pearl-Index < 1%) during the study and at least 6 months thereafter

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Serious complications (leukemia associated) or concomitant diseases, such as
- severe uncontrollable complications (leukemia associated), i.e. sepsis, pneumonia with hypoxia, shock, bleeding at diagnosis
- renal insufficiency, if not caused by leukemia
- severe impairment of heart or liver function (if not caused by leukemic infiltration)
- severe obstructive or restrictive pulmonary disease
- known HIV infection or other uncontrolled infections
- any other condition that compromises the patient’s eligibility for intensive treatment as described by the study protocol

• Late relapse of childhood leukemia or concurrent malignancy

• Previous cytostatic treatment
- ALL directed (exceptions: standard prephase, application of steroids = 7 days, once-only application of vincristine, cyclophosphamide or other substances as emergency medical intervention)
- directed to other malignancies within the last 10 years before diagnosis of ALL

• Pregnancy or breastfeeding

• Severe psychiatric disease or any severe concomitant condition under which the patient's understanding of importance and consequences of study participation and/or compliance and therapy according to study protocol cannot be expected

• At diagnosis: participation in another trial that interferes with the antileukemic treatment
(exceptions: trials aiming at supportive care, defined accompanying GMALL trials, and at a later timepoint trials with experimental substances, i. e. in case of molecular treatment failure)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified